Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure (BRIGHTEN-HF)

March 23, 2026 updated by: Impulse Dynamics

Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)

The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Data for both the CCM treatment arm and a propensity-matched control group come from a large, de-identified, aggregated electronic health record (EHR) database containing patient information from multiple U.S. healthcare systems. The database includes demographics, clinical notes, imaging, laboratory results, medications, social determinants of health, and other relevant healthcare information, with up to 8 years of historical clinical data updated regularly.

Study Type

Observational

Enrollment (Estimated)

4200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants are patients with heart failure who are identified from a large, de-identified, multi-system electronic health record (EHR) database representing diverse healthcare settings across the United States. The database includes patients receiving care in hospitals, outpatient clinics, and other sites where cardiac contractility modulation (CCM) therapy is delivered. The population reflects typical sites of CCM implantation in Medicare-eligible adults across multiple states and integrated delivery networks (IDNs).

Description

Inclusion Criteria

  1. Continuous representation in the database in the year prior to index.
  2. Age 18 or older will be enrolled in either the treatment or control arm of the study.
  3. NYHA III heart failure,
  4. Not receiving CRT
  5. EF 25 - 45%, inclusive.
  6. Remain symptomatic despite at least 3 months of optimized guideline-directed medical therapy (GDMT) as determined by the heart team prior to CCM implantation.

Exclusion Criteria

  1. Subject has had a prior heart transplant
  2. Subject with mechanical tricuspid valve.
  3. Subject has a left ventricular assist device (LVAD).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Treatment patients shall be those with a clinical indication for CCM implantation according to FDA approved labeling and who are implanted with the Optimizer System.
Device: Cardiac Contractility Modulation (CCM)
CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.
Control Group
The control group shall be derived from propensity score matching of patients derived from the database with a clinical indication for CCM implantation who do not receive an implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first heart failure hospitalization or all-cause death
Time Frame: Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.
Time from index date to the first occurrence of either heart failure-related hospitalization or death in patients with a clinical indication for cardiac contractility modulation (CCM) therapy. Outcomes will be compared between patients implanted with the Optimizer System (treatment arm) and a propensity score-matched control group of patients who are eligible for CCM but did not receive the device. Data will be collected from a large, de-identified, multi-system electronic health record database representing diverse sites of care across the United States.
Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrent heart failure hospitalization
Time Frame: Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.
Time from index date (CCM implantation for treatment patients) to each heart failure-related hospitalization, including first and subsequent hospitalizations, in patients receiving CCM therapy compared with a matched control group of patients eligible for CCM but not treated. This outcome is exploratory and hypothesis-generating.
Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.
Time to all-cause mortality
Time Frame: Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.
Time from index date (CCM implantation for treatment patients) to death from any cause, in patients receiving CCM therapy compared with a matched control group of patients eligible for CCM but not treated. This outcome is exploratory and hypothesis-generating.
Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impulse Dynamics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Actual)

October 6, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA_CP_2558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NYHA Class III Heart Failure

Clinical Trials on Cardiac Contractility Modulation (CCM)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe